During the Barcelona Health Innovation Week, Asphalion hosted an insightful workshop on “Regulatory Tips for AI & Software-Based Medical Technologies.” Experts from diverse backgrounds came together to delve into the regulatory landscape of AI in medical devices.
Among the speakers was ERNI’s Managing Director, Albert Alsina. ERNI is a Swiss Software Engineering company. In this video, Albert talks about how many of their customers had products that were not Medical Devices, but these became Medical Devices after the change of regulation.
Some learnings:
- Adopt the new regulation from the beginning
- Start transitioning asap
- If the compilation management is automatized, it reduces the verification process.
- All medical devices incorporating AI are considered high-risk
Watch this short clip of his detailed insights on regulatory compliance in AI-based medical technology and key learnings from the workshop here: AI WORKSHOP
If you need any assistance with your medical devices, please contact us at: [email protected]
